Program; establishment; administration; rules and regulations; patients; certification; confidentiality of names and records

a. There is hereby established in the State Department of Health, the controlled dangerous substances therapeutic research program. The program shall be limited to therapeutic research programs presently conducted by the Bureau of Drugs in the Food and Drug Administration of the U.S. Department of Health and Human Services or its successor and shall be administered by the commissioner who shall promulgate rules and regulations necessary for the administration of this act, including but not limited to rules and regulations which may be necessary to require patients desiring certification pursuant to section 5 of this act to release their medical records for the purposes of certification and follow-up reports. In making such promulgations, the commissioner shall take into consideration all Federal controlled dangerous substances laws and rules adopted pursuant to such laws. b. The program shall be limited to patients who are certified to the board, established by section 5 of this act, by a practitioner as being involved in a life-threatening or sense-threatening situation and who are not responding to drugs or where the drugs administered have proven to be effective but where the patient has incurred severe side effects. c. The names and medical records of individual patients who have either requested certification or have been certified pursuant to section 5 of this act shall not be released in any form which identifies the individual, except that the names and records of such individuals shall be made available upon request for use in the enforcement of laws regarding controlled dangerous substances (P.L.1970, c. 226; C. 24:21-1 et seq.).